MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 11MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products - three peg patella 29mm (cat# 200-02-29 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the female patient had an original exactech left tka.The patient presented back to surgeon's office with complaints of pain, swelling, instability, and dissatisfaction with their left tka.The patient has a recalled implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.The patient had revision surgery on (b)(6) 2023.The patient underwent a left tka tibial poly swap and patella implant swap and revised to a truliant crc insert size 1.5, 13mm and optetrak 3 peg patella cemented 29m.The patient left the operating room (or) stable.There was no breakage of a device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.The devices are not available for evaluation due the implant was required to be sent to the lab and legal at the hospital.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d6a, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The revision reported was likely due to the reported instability, or due to the inclusion of the polyethylene tibial insert in the packaging recall.Prosthesis wear of the patella appears to be an incidental finding during revision and does not appear to be the cause for the revision.Additional reasons for the reported revision may be tibial insert prosthesis wear and instability; however, the reported instability and tibial insert prosthesis wear could not be confirmed from the provided information.Additionally, a contributing factor to the reported wear may have been the result of the tibial insert being packaged in a non-conforming vacuum bag for more than five years.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16786177
• Report Number: 1038671-2023-00792
• Device Sequence Number: 5692007
• Product Code: JWH
• UDI-Device Identifier: 10885862144416
• UDI-Public: 10885862144416
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 11MM
• Device Catalogue Number: 02-012-49-1511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T; LOGIC CR FEMORAL CEM, LEFT SZ 1.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female